1 open position available
Lead clinical study programming activities, manage external resources, ensure regulatory compliance and timely delivery of high-quality data products. | Bachelor's degree plus 8 years of clinical research programming experience with advanced SAS skills and knowledge of CDISC standards. | We are seeking an experienced Senior Leader to oversee clinical study programming activities and ensure timely delivery of high-quality data products. This role requires advanced knowledge of CDISC standards, medical terminology, and clinical trial methodologies. Job Responsibilities: • Lead clinical studies and manage external resources to ensure compliance with regulatory agencies and data reporting standards. • Organize and prioritize programming activities, including production and quality control of datasets and outputs. • Collaborate with internal cross-functional teams to ensure study deliverables are on time and of high quality. • Apply advanced knowledge of CDISC standards (SDTM and ADaM), medical terminology, clinical trial methodologies to ensure compliance with regulatory agencies and data reporting standards. Requirements: • Bachelor's degree in Statistics, Math, Pharmaceutical Sciences, or related field. • 8 years of experience in clinical research programming, including program analysis, quality control checks, and statistical analysis. • Advanced knowledge of SAS procedures, including Freq, Univariate, Means, and sgplot. • Experience with creating standard macros and adapting them to multiple studies. • Strong communication and project management skills. Benefits: • Competitive compensation package. • Full-time position with up to 75% remote work allowed. • Opportunities for professional growth and development.
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